ANDA 204748

MYLAN LABS LTD

FDA Drug Application

Application #204748

Documents

• Letter: 2017-10-12

Application Sponsors

ANDA 204748

MYLAN LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 150MG BASE/ML

0

CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-10-10

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204748
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN PHOSPHATE","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 150MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/10\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204748Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-10
        )

)